TRAPADEX 37.5 MG / 325 MG FILM-COATED-TABLETS, TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG / 325 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Trapadex 37.5mg/325mg, film-coated tablets

Tramadol hydrochloride/Pa­racetamol

This medicine contains Tramadol hydrochloride which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Trapadex is and what it is used for

• 2. What you need to know before you take Trapadex

• 3. How to take Trapadex

• 4. Possible side effects

• 5. How to store Trapadex

• 6. Contents of the pack and other information

1. what trapadex is and what it is used for

Trapadex is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.

2. what you need to know before you take trapadexdo not take trapadex: if you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients (see section 6) in trapadex

• in cases of acute alcohol poisoning
• if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions
• if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Trapadex. MAOIs are used in the treatment of depression or Parkinson’s di­sease.
• if you have a severe liver disorder
• if you have epilepsy that is not adequately controlled by your current medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Trapadex if you:

• take other medicines containing paracetamol or tramadol
• have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice
• have kidney problems
• have severe difficulties in breathing, for example asthma or severe lung problems
• have epilepsy or have already experienced fits or seizures
• have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick)
• are dependent on any medicine (for example morphine)
• take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine are going to have an anaesthetic (tell your doctor or dentist that you are taking Trapadex).
• if you are going to have an anaesthetic (tell your doctor or dentist that you are taking Trapadex).
• if you suffer from depression and you are taking antidepressants as some of them may interact with trapadex (see ‘Other medicines and Trapadex’)

There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).

Sleep-related breathing disorders

Trapadex contains an active substance that belongs to the group of opioids. Opioids can cause sleeprelated breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).

The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea.

If any of the above-mentioned points applied to you in the past or applies to you while you are taking Trapadex, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.

Other medicines and Trapadex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with Trapadex.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.

Do not take Trapadex with MAOIs (see section ‘Do not take Trapadex’).

Trapadex is not recommended with the following medicines, as it may affect how well they work:

• carbamazepine (a medicine used to treat epilepsy or some types of pain)
• buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers).

The risk of side effects increases:

• if you are taking triptans (used for migraine) or selective serotonin re-uptake inhibitors (SSRIs, used for depression). Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea.
• if you are taking other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant), medicines used to lower blood pressure, or medicines to treat allergies. Check with your doctor if you feel drowsy or feel faint.

Concomitant use of Trapadex and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor prescribes Trapadex together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

• if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Trapadex at the same time. Your doctor will tell you whether Trapadex is suitable for you.
• if you are taking certain antidepressants. Trapadex may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
• if you are taking warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4).

The effectiveness of Trapadex may be altered if you also take the following medicines:

• metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/bein­g sick)
• cholestyramine (medicine used to reduce cholesterol in the blood)
• ketoconazole or erythromycin (medicines used against infections).

Trapadex with food and drink

Do not drink alcohol while you are taking Trapadex, as you may feel drowsy.

Pregnancy and breast-feeding

Do not take Trapadex while you are pregnant or breast-feeding.

Check with your doctor if you become pregnant during treatment with Trapadex and before taking any further tablets. Tramadol is excreted into breast milk. For this reason, you should not take Trapadex more than once during breast-feeding, or alternatively, if you take Trapadex more than once, you should stop breast-feeding.

Based on human experience tramadol is suggested not to influence female or male fertility. No data on the influence of the combination of tramadol and paracetamol on fertility are available.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you feel drowsy while taking Trapadex, do not drive, use tools or use machinery. The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

• – The medicine has been prescribed to treat a medical or dental problem and

• – You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

• – It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. how to take trapadex

Always take this medicine as you doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

Swallow the tablets whole with sufficient liquid. Do not break or chew the tablets.

Take Trapadex for as short a time as possible and no longer than your doctor has told you.

Adults and adolescents over 12 years:

The recommended starting dose unless otherwise prescribed by your doctor is 2 tablets for adults and adolescents over 12 years. If required, further doses may be taken, as instructed by your doctor.

The shortest time between doses must be at least 6 hours.

Do not take more than 8 tablets per day.

• Children under 12 years of age: not recommended.

Older people:

In elderly patients (above 75 years) the excretion of tramadol may be delayed.

If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or kidney disease (insufficiency)/di­alysis patients:

Patients with severe liver and/or kidney insufficiency should not take Trapadex. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration:

The tablets are for oral use.

Swallow the tablets whole with sufficient liquid.

Do not break or chew the tablets.

If you think that the effect of Trapadex is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.

If you take more Trapadex than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take Trapadex

If you forget to take the tablets, pain is likely to return.

Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.

If you stop taking Trapadex

Generally, there will be no after-effects when treatment with Trapadex is stopped.

Rarely, people who have been using a medicine containing tramadol may become dependent on it, making it hard to stop taking it. If you have been taking Trapadex for some time and want to stop, contact your doctor because your body may have become used to Trapadex. People may:

• feel agitated, anxious, nervous or shaky
• be over active
• have difficulty sleeping
• have stomach or bowel disorders.

Very few people may also get:

• panic attacks
• hallucinations, unusual perceptions such as itching, tingling and numbness
• ringing in the ears

If you experience any of these complaints after stopping this medicine, please contact your doctor. Other side effect information is listed in section 4

4. possible side effects

Like all medicines, Trapadex can cause side effects, however not everybody gets them.

Some side effects could be serious. Contact your doctor immediately if any of the following occur:

• rarely cases of skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment. Do not take the medicine again.
• prolonged or unexpected bleeding, from the use of Trapadex with medicines used to thin the blood (e.g. warfarin, phenprocoumon).

Additionally, if any of the following side effects get serious, contact your doctor or pharmacist:

Very common: may affect more than 1 in 10 people

• nausea
• dizziness, drowsiness

Common: may affect up to 1 in 10 people

• vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth
• itching, sweating (hyperrhidrosis)
• headache, shaking
• confusional state, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits).

Uncommon: may affect up to 1 in 100 people

• increase in pulse or blood pressure, heart rate or heart rhythm disorders
• presence of albumin in urine, difficulties or pain on passing urine
• skin reactions (for example rashes, hives)
• tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle twitching
• depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), memory lapses
• difficulty swallowing, blood in the stools
• shivering, hot flushes, pain in the chest
• difficulty breathing.
• increase in liver enzyme values

Rare: may affect up to 1 in 1,000 people

• fits, uncoordinated movements, translate loss of consciousness (syncope)
• drug dependance
• delirium
• blurred vision, constriction of pupil (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis)

Not known: frequency cannot be estimated from the available data

• decrease in blood sugar level (hypoglycaemia)
• serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take Tramadol hydrochloride 50mg capsules’).

In addition, the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol:

• feeling faint when getting up from a lying or sitting position, slow heart rate, fainting
• changes in appetite
• muscle weakness, slower or weaker breathing
• mood changes, changes in activity, changes in perception
• worsening of existing asthma
• nose bleed or bleeding gums, which may result from a low blood platelet count.
• very rare cases of serious skin reactions have been reported with paracetamol.
• rare cases of respiratory depression have been reported with tramadol.

5. how to store trapadex

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is printed on the carton and blister. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat trapadex containsthe active substances are tramadol hydrochloride and paracetamol.

One tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol. The other ingredients are: Tablet core: Pregelatinised starch, maize starch, sodium starch glycolate, microcrystalline cellulose, magnesium stearate

Film-coating: Hypromellose (E464), Titanium dioxide (E171), Triacetin, Iron oxide yellow (E172)

What Trapadex looks like and contents of the pack

Light yellow, oblong, biconvex, film-coated tablet, plain on both sides.

Trapadex comes in cartons of 60 tablets and 20 tablets.

Marketing Authorisation Holder and Manufacturer:

NO NOUMED LIFE SCIENCES LIMITED M Noumed House, Shoppenhangers Road

Maidenhead, Berkshire, SL6 2RB, United Kingdom.

This leaflet was last revised in July 2021

Other sources of information:

To listen to or request a copy of this leaflet in braille, large print or audio

please call, 020 33998960 (UK only)

Please be ready to give the following information:

Product name: Trapadex 37.5mg/325mg, film-coated tablets

Reference number: PL 44041/0053

LTRAP01/01